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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number UNKN01100102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after a medically indicated conversion of previous left hip surgery to total hip arthroplasty to repair a non union performed on (b)(6) 2015, where redapt modular slvd stem 240mm sz 19 was implanted, the patient experienced draining wound at distal aspect of hip incision. The wound was warm on touch and the patient had an infected picc line confirmed on blood test. An incision and drainage of a wound was planned 6 weeks after the surgery, but no confirmation was received. The patient continued having the draining wound and an overwhelming infection was reported 3 months postop. Device explantation was indicated, however a revision surgery was not confirmed. Additional details about primary surgery are unknown. Patient outcome is unknown. This de-identified clinical data is related to a post market clinical follow-up activity for redapt sleeved mono stems. As the data collection activity has been done retrospectively and data is provided anonymized, the information provided is limited and further information cannot be obtained.
 
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Brand NameUNKN REDAPT MONOBLOCK STEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12524232
MDR Text Key273078579
Report Number1020279-2021-07126
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN01100102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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